Atorvastatin Calcium

Orange BookUNIISPLATC C10AA05

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerDr. Reddy's Laboratories Inc

CountryUS (United States)

ATC codeC10AA05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
4359809905
500 TABLET in 1 BOTTLE (43598-099-05)
ndc11
4359809978
10 BLISTER PACK in 1 CARTON (43598-099-78) / 10 TABLET in 1 BLISTER PACK (43598-099-10)
ndc11
4359809990
90 TABLET in 1 BOTTLE (43598-099-90)

Annotations

UNII (FDA Substance ID)

48A5M73Z4Q

ATORVASTATIN CALCIUM TRIHYDRATE

RxCUI 1297766

Orange Book

A214659

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "48A5M73Z4Q",
    "rxcui": "1297766",
    "inchikey": "SHZPNDRIDUBNMH-NIJVSVLQSA-L",
    "display_name": "ATORVASTATIN CALCIUM TRIHYDRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "52f99e39-fb92-e9f5-e063-6294a90a1b6a": {
      "match": "brand_token",
      "title": "ATORVASTATIN CALCIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "43598-099_d4e74ed4-46a8-d079-8e3e-299f10d739cd",
  "productndc": "43598-099",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "214659",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Jul 14, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Jul 14, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "003",
        "approval_date": "Jul 14, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 80MG BASE",
        "product_no": "004",
        "approval_date": "Jul 14, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ATORVASTATIN CALCIUM TRIHYDRATE",
  "proprietary_name": "Atorvastatin Calcium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA214659",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Atorvastatin Calcium",
  "start_marketing_date": "20240401",
  "active_numerator_strength": "20"
}

Related drugs

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